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510(k) Data Aggregation
K Number
K251339Device Name
Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
Manufacturer
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Date Cleared
2025-07-25
(86 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Zhengzhou PZ Laser Slim Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K250782Device Name
Fractional CO2 Laser Machine
Manufacturer
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Date Cleared
2025-06-12
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Zhengzhou PZ Laser Slim Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- CO2 LASER Part:
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode (Impulse mode) is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
Device Description
The Fractional CO2 Laser Machine uses a CO2 laser with the emission wavelength of 10600nm to emit focal spots through a high focus lens. The target is water in skin tissue. A certain amount of thermal stripping, more thermal coagulation and obvious thermal effect are produced at the part directly penetrated by the focal spot.
The Fractional CO2 Laser Machine has two operational modes, fractional mode and impulse mode.
- Fractional mode includes three modes: normal, random and midsplit;
- Impulse mode includes three modes: single, continuous and impulse.
The Fractional CO2 Laser Machine has 5 modules: Control display panel module, Main control power module, Light guide arm module, Fan cooling module, Laser module.
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K Number
K250038Device Name
Muscle Stimulator Device (PZ-100)
Manufacturer
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Date Cleared
2025-05-19
(131 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Zhengzhou PZ Laser Slim Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Muscle Stimulator Device is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms.
Device Description
The Muscle Stimulator Device (model PZ-100) is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device has four outputs, and two applicators perform simultaneous treatment.
The Muscle Stimulator Device is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The Muscle Stimulator Device is composed of control display panel module, main control module, temperature module, treatment handle module, and fan cooling module.
The proposed device can simultaneously apply multiple treatment handles to patients, and the handles are held in place by bandages.
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K Number
K250041Device Name
Medical Picosecond ND: YAG Laser System (PZ-6)
Manufacturer
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Date Cleared
2025-05-14
(126 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Zhengzhou PZ Laser Slim Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical Picosecond ND:YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
**1064nm wavelength:**
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
**532nm wavelength:**
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Device Description
The Medical Picosecond ND: YAG Laser System mainly consists of a host, a light guide arm, a treatment handle, a foot switch, a power cord, and other auxiliary treatment accessories. The host mainly includes laser power supply, laser, water circulation cooling system, control board, and display screen. Accessories include a foot switch, laser protective glasses, power cords, and a water filling funnel.
The Medical Picosecond ND: YAG Laser System is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).
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